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news.Bayer HealthCare Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a new oral contraceptive (OC), Safyral (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets).
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Safyral raises the folate levels in women who choose OC for birth control for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking SAFYRAL or shortly after discontinuing it.
Safyral provides the birth control Yasmin (drospirenone 3 mg/ ethinyl estradiol 30 mcg) in combination with 451 mcg levomefolate calcium, which is a B vitamin.
Safyral is the second Bayer OC which contains folate, which has been approved by the FDA.
In September, Bayer received FDA approval for Beyaz, which is the first OC approved by the FDA to raise folate levels in women who choose an OC for birth control
Bayer HealthCare Pharmaceuticals Women’s HealthCare vice president of Marketing, Leslie North said with the FDA approval of Safyral, Bayer now offers two oral contraceptives that contain folate.
"SAFYRAL and Beyaz are part of Bayer’s growing women’s health franchise, and these new products reinforce our commitment to providing women various contraceptive options," North said.